Examples of FDA Approval in a sentence
As of the Effective Date, the Product has not received FDA Approval.
Seller and its Affiliates have commenced, will commence, or Seller shall cause its Affiliates to commence, Marketing in the United States of the Rare Pediatric Disease product for which the Priority Review Voucher was awarded [***] period beginning on the date of the FDA Approval of such Rare Pediatric Disease product (such period, the “Marketing Period”).
The Seller shall, directly or indirectly through its Affiliates or any Collaboration Partners, use Commercially Reasonable Efforts to conduct its Product Commercialization and Development Activities, to obtain SNDA FDA Approval and to Commercialize the Product within its approved indications for use.
As of the Effective Date, the Company is planning to conduct all Clinical Trials, including Phase 3 Clinical Trials, necessary to (a) meet the Phase 3 Success Criteria and (b) receive FDA Approval, in each case of clauses (a) and (b), for the Product as the Product exists as of the Effective Date.